Study Summary
This trial will compare the effectiveness of a combination of AAT and corticosteroids to corticosteroids alone as the first treatment for patients at high risk for developing acute GVHD.
- Graft-versus-Host Disease
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: up to 12 months post-randomization
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
AAT
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
136 Total Participants · 2 Treatment Groups
Primary Treatment: Alpha-1 antitrypsin (AAT) · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age Any Age · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Has AAT been cleared by the FDA for therapeutic use?
"There is some evidence for AAT's efficacy and it has undergone multiple rounds of testing, so it has been deemed safe and given a score of 3." - Anonymous Online Contributor
Can patients still sign up for this program?
"The listed clinical trial on clinicaltrials.gov is still recruiting patients. This trial was originally posted on 2020-01-09 and was most recently updated on 2022-08-12." - Anonymous Online Contributor
How many individuals are being treated in this clinical trial?
"The study requires a total of 122 participants that fit the inclusion criteria. The sponsor, CSL Behring, will administer the trial from their locations in Richmond, Virginia and Ann Arbor, Michigan." - Anonymous Online Contributor